Actively Recruiting

Age: 18Years +
All Genders
NCT06899113

Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

Led by MIMOSA Diagnostics Inc. · Updated on 2025-09-11

60

Participants Needed

1

Research Sites

28 weeks

Total Duration

On this page

Sponsors

M

MIMOSA Diagnostics Inc.

Lead Sponsor

N

Northwell Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this observational study is to learn if the measures of tissue oxygenation from the MIMOSA Pro imaging device correlate to standard vascular assessment tools in patients who receiving a lower extremity vascular assessment. The main questions it aims to answer are: * Do the MIMOSA Pro tissue oxygenation measures correlate to Ankle-Brachial Index, Toe-Brachial Index, transcutaneous oximetry, and Doppler wave forms? * Do the MIMOSA Pro tissue oxygenation measures correlate with disease classifications for peripheral arterial disease, venous disease, and wound stage? * Is the MIMOSA Pro able to measure vascular status more often than other modalities? Participants will be asked to follow standard of care, and also allow for their legs to imaged by the MIMOSA Pro.

CONDITIONS

Official Title

Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provision of signed and dated informed consent form
  • Willingness to comply with all study procedures and available for the study duration
  • Male or female, aged 18 and older
  • Undergoing an ankle-brachial index (ABI) test
  • Recently had or will have further vascular assessment as part of standard care, including transcutaneous oxygen pressure and Doppler waveforms
  • Able to be followed by the same investigating team throughout the study
Not Eligible

You will not qualify if you...

  • Participating in another clinical study for ulcer management
  • Unable to understand the study aims or provide informed consent
  • Receiving radiation to the extremity
  • Having active Charcot joints

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Northwell Health Comprehensive Wound Healing Center

Lake Success, New York, United States, 11042

Actively Recruiting

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Research Team

A

Alisha Oropallo, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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